ý
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
33-0655706
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
Common Stock, $0.001 par value
|
|
NASDAQ Global Select Market
|
(Title of each class)
|
|
(Name of each exchange on which listed)
|
Large accelerated filer
¨
|
|
Accelerated filer
ý
|
|
Non-accelerated filer
¨
|
|
Smaller reporting company
¨
|
|
|
|
|
(Do not check if a smaller
reporting company)
|
|
|
|
|
Page No.
|
Part I
|
|
|
|
|
|
Item 1:
|
Business
|
|
Item 1A:
|
Risk Factors
|
|
Item 1B:
|
Unresolved Staff Comments
|
|
Item 2:
|
Properties
|
|
Item 3:
|
Legal Proceedings
|
|
Item 4:
|
Mine Safety Disclosures
|
|
|
|
|
Part II
|
|
|
|
|
|
Item 5:
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
|
|
Item 6:
|
Selected Financial Data
|
|
Item 7:
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
Item 7A:
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
Item 8:
|
Financial Statements and Supplementary Data
|
|
Item 9:
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
|
Item 9A:
|
Controls and Procedures
|
|
Item 9B:
|
Other Information
|
|
|
|
|
Part III
|
|
|
|
|
|
Item 10:
|
Directors, Executive Officers and Corporate Governance
|
|
Item 11:
|
Executive Compensation
|
|
Item 12:
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
|
Item 13:
|
Certain Relationships and Related Transactions, and Director Independence
|
|
Item 14:
|
Principal Accounting Fees and Services
|
|
|
|
|
Part IV
|
|
|
|
|
|
Item 15:
|
Exhibits, Financial Statement Schedules
|
|
Signatures
|
•
|
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
|
•
|
submission to the FDA of an investigational new drug, or IND, application, which must take effect before human clinical trials may begin;
|
•
|
approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug product for each indication;
|
•
|
preparation and submission to the FDA of an NDA, requesting marketing for one or more proposed indications;
|
•
|
review by an FDA advisory committee, where appropriate or if applicable;
|
•
|
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
|
•
|
satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;
|
•
|
payment of user fees and securing FDA approval of the NDA; and
|
•
|
compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies.
|
•
|
Phase 1.
The drug is initially introduced into a small number of healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition (e.g., cancer) and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage.
|
•
|
Phase 2.
The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
|
•
|
Phase 3.
These clinical trials are commonly referred to as “pivotal” studies, which denotes a study that presents the data that the FDA or other relevant regulatory agency will use to determine whether or not to approve a drug. The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, identify adverse effects, establish the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.
|
•
|
Phase 4.
Post-approval studies may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication.
|
•
|
restrictions on the marketing or manufacturing of the product, suspension of the approval, or complete withdrawal of the product from the market or product recalls;
|
•
|
fines, warning letters or holds on post-approval clinical trials;
|
•
|
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the required patent information has not been filed;
|
•
|
the listed patent has expired;
|
•
|
the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
|
•
|
the listed patent is invalid, unenforceable or will not be infringed by the new product.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government.
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
|
•
|
the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
|
•
|
an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications;
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
•
|
expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices and extending rebate liability to prescriptions for individuals enrolled in Medicare Advantage plans;
|
•
|
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
•
|
expanded the types of entities eligible for the 340B drug discount program;
|
•
|
established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
the Independent Payment Advisory Board, or IPAB, which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription drugs. However, the IPAB implementation has been not been clearly defined. ACA provided that under certain circumstances, IPAB recommendations will become law unless Congress enacts legislation that will achieve the same or greater Medicare cost savings; and
|
•
|
established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. Funding has been allocated to support the mission of the Center for Medicare and Medicaid Innovation from 2011 to 2019.
|
Name
|
|
Age
|
|
Position
|
|
Adelene Q. Perkins
|
|
57
|
|
|
Chief Executive Officer
|
Lawrence E. Bloch, M.D., J.D.
|
|
51
|
|
|
President and Treasurer
|
Jeffery L. Kutok, M.D., Ph.D.
|
|
50
|
|
|
Senior Vice President, Chief Scientific Officer
|
Seth A. Tasker, J.D.
|
|
38
|
|
|
Vice President, General Counsel and Secretary
|
•
|
the scope, progress, results and costs of developing IPI-549, currently in clinical development;
|
•
|
our ability to realize the planned cost savings benefits of strategic restructurings we effected in 2016, which included a significant reduction in our workforce, in order to preserve capital to support the development of IPI-549;
|
•
|
our ability to secure alternative leasing or subleasing arrangements for our current lease and to achieve related cost savings;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for IPI-549;
|
•
|
our ability to effectively transition the duvelisib program to Verastem;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
|
•
|
the absence of any breach, acceleration event or event of default under any agreements with third parties;
|
•
|
the outcome of any lawsuits that could be brought against us;
|
•
|
the cost of acquiring raw materials for, and of manufacturing, our product candidates is higher than anticipated;
|
•
|
the cost or quantity required of comparator drugs used in clinical studies increases; and
|
•
|
a loss in our investments due to general market conditions or other reasons.
|
•
|
initiation and successful enrollment and completion of clinical trials, including in combination with other agents;
|
•
|
a safety, tolerability and efficacy profile that is satisfactory to the U.S. Food and Drug Administration, or FDA, or any comparable foreign regulatory authority for marketing approval;
|
•
|
timely receipt of marketing approvals from applicable regulatory authorities;
|
•
|
the extent of any required post-marketing approval commitments to applicable regulatory authorities;
|
•
|
establishment of supply arrangements with third-party raw materials suppliers and manufacturers;
|
•
|
establishment of arrangements with third-party manufacturers to obtain finished drug product that is appropriately packaged for sale;
|
•
|
adequate ongoing availability of raw materials and drug product for clinical development and any commercial sales;
|
•
|
obtaining and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and internationally;
|
•
|
protection of our rights in our intellectual property portfolio;
|
•
|
successful launch of commercial sales following any marketing approval;
|
•
|
a continued acceptable safety profile following any marketing approval;
|
•
|
commercial acceptance by patients, the medical community and third-party payors; and
|
•
|
our ability to compete with other therapies.
|
•
|
unfavorable results of discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
|
•
|
delays in receiving, or the inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;
|
•
|
delays in enrolling patients into clinical trials;
|
•
|
a lower than anticipated retention rate of patients in clinical trials;
|
•
|
the need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;
|
•
|
inadequate supply, delays in distribution or deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;
|
•
|
unfavorable FDA or other foreign regulatory inspection and review of a clinical trial site, Infinity, or an Infinity vendor, or records of any clinical or preclinical investigation;
|
•
|
serious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;
|
•
|
a finding that the trial participants are being exposed to unacceptable health risks;
|
•
|
the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial; or
|
•
|
any restrictions on, or post-approval commitments with regard to, any regulatory approval we ultimately obtain that render the product candidate not commercially viable.
|
•
|
regulators or institutional review boards may not authorize us, any collaborators or our or their investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we, or any collaborators, may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
|
•
|
clinical trials of IPI-549 may produce unfavorable or inconclusive results;
|
•
|
we, or any collaborators, may decide, or regulators may require us or them, to conduct additional clinical trials or abandon IPI-549;
|
•
|
the number of patients required for clinical trials of IPI-549 may be larger than we, or any collaborators, anticipate, patient enrollment in these clinical trials may be slower than we, or any collaborators, anticipate or participants may drop out of these clinical trials at a higher rate than we, or any collaborators, anticipate;
|
•
|
the cost of planned clinical trials of IPI-549 may be greater than we anticipate;
|
•
|
our third-party contractors or those of any collaborators, including those manufacturing IPI-549 or components or ingredients thereof or conducting clinical trials on our behalf or on behalf of any collaborators, may fail to comply with regulatory requirements or meet their contractual obligations to us or any collaborators in a timely manner or at all;
|
•
|
patients that enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;
|
•
|
we, or any collaborators, may have to delay, suspend or terminate clinical trials of IPI-549 for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of IPI-549;
|
•
|
regulators or institutional review boards may require that we, or any collaborators, or our or their investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their standards of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of IPI-549 or findings of undesirable effects caused by a chemically or mechanistically similar product or product candidate;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our, or any collaborators’, clinical trial designs or our or their interpretation of data from preclinical studies and clinical trials;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we, or any collaborators, enter into agreements for clinical and commercial supplies;
|
•
|
the supply or quality of raw materials or manufactured product candidates or other materials necessary to conduct clinical trials of IPI-549 may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.
|
•
|
the size and nature of the patient population;
|
•
|
the severity of the disease under investigation;
|
•
|
the nature and complexity of the trial protocol, including eligibility criteria for the trial;
|
•
|
the number of clinical trial sites and the proximity of patients to those sites;
|
•
|
standard of care in disease under investigation;
|
•
|
the commitment of clinical investigators to identify eligible patients;
|
•
|
competing studies or trials; and
|
•
|
clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
|
•
|
the inclusion of a placebo arm in a trial;
|
•
|
possible inactivity or low activity of the product candidate being tested at one or more of the dose levels being tested;
|
•
|
the occurrence of adverse side effects, whether or not related to the product candidate; and
|
•
|
the availability of numerous alternative treatment options, including clinical trials evaluating competing product candidates, that may induce patients to discontinue their participation in the trial.
|
•
|
timing of our receipt of any marketing approvals, the terms of any such approvals and the countries in which any such approvals are obtained;
|
•
|
timing of market introduction of competitive products;
|
•
|
lower demonstrated clinical safety or efficacy, or less convenient or more difficult route of administration, compared to competitive products;
|
•
|
lack of cost-effectiveness;
|
•
|
lack of reimbursement from government payors, managed care plans and other third-party payors;
|
•
|
prevalence and severity of side effects;
|
•
|
potential advantages of alternative treatment methods;
|
•
|
whether it is designated under physician treatment guidelines as a first, second or third line therapy;
|
•
|
changes in the standard of care for targeted indications;
|
•
|
limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;
|
•
|
safety concerns with similar products marketed by others;
|
•
|
the reluctance of the target population to try new therapies and of physicians to prescribe those therapies;
|
•
|
the lack of success of our physician education programs; and
|
•
|
ineffective sales, marketing and distribution support.
|
•
|
decides not to devote the necessary resources because of internal constraints, such as limited personnel with the requisite scientific or commercial expertise, limited cash resources or specialized equipment limitations;
|
•
|
decides not to pursue development and commercialization of the program or to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding, the belief that other product candidates may have a higher likelihood of obtaining regulatory approval or potential to generate a greater return on investment, or external factors, such as an acquisition, that divert resources or create competing priorities;
|
•
|
does not perform its obligations as expected;
|
•
|
does not have sufficient resources necessary or is otherwise unable to carry the program through clinical development, regulatory approval and commercialization;
|
•
|
cannot obtain the necessary regulatory approvals;
|
•
|
delays clinical trials, provides insufficient funding for a clinical trial program, stops a clinical trial or abandons the program, repeats or conducts new clinical trials or requires a new formulation of the program for clinical testing;
|
•
|
independently develops, or develops with third parties, products that compete directly or indirectly with the program;
|
•
|
does not commit sufficient resources to the marketing and distribution of such product or products;
|
•
|
does not properly maintain or defend our intellectual property rights or uses our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
|
•
|
infringes the intellectual property rights of third parties, which may expose us to litigation and potential liability; or
|
•
|
terminates the collaboration prior to its completion.
|
•
|
pay substantial damages;
|
•
|
stop developing, manufacturing and/or commercializing IPI-549;
|
•
|
develop non-infringing product candidates, technologies and methods; and
|
•
|
obtain one or more licenses from other parties, which could result in our paying substantial royalties or the granting of cross-licenses to our technologies.
|
•
|
restrictions on such products, manufacturers or manufacturing processes;
|
•
|
restrictions on the labeling or marketing of a product;
|
•
|
restrictions on distribution or use of a product;
|
•
|
requirements to conduct post-marketing studies or clinical trials;
|
•
|
warning letters or untitled letters;
|
•
|
withdrawal of the products from the market;
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
•
|
recall of products;
|
•
|
damage to relationships with any potential collaborators;
|
•
|
unfavorable press coverage and damage to our reputation;
|
•
|
fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
refusal to permit the import or export of our products;
|
•
|
product seizure;
|
•
|
injunctions or the imposition of civil or criminal penalties; and
|
•
|
litigation involving patients using our products.
|
•
|
the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation or arranging of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per-claim penalties, currently set at $5,500 to $11,000 per false claim;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians and teaching hospitals; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency statutes, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers.
|
•
|
an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
•
|
expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
|
•
|
expansion of eligibility criteria for Medicaid programs;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements to report certain financial arrangements with physicians and teaching hospitals;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
a new Independent Payment Advisory Board, or IPAB, which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription drugs; and
|
•
|
established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models.
|
•
|
the results of our current and any future clinical trials of IPI-549;
|
•
|
the timing and costs associated with the wind-down of our involvement with duvelisib;
|
•
|
future sales of, and the trading volume in, our common stock;
|
•
|
announcements of strategic transactions relating to our programs or our company;
|
•
|
our entry into key agreements, including those related to the acquisition or in-licensing of new programs, or the termination of key agreements, including our amended and restated development and license agreement with Takeda or the Verastem Agreement;
|
•
|
the results and timing of regulatory reviews relating to the approval of IPI-549;
|
•
|
the initiation of, material developments in, or conclusion of litigation, including but not limited to litigation to enforce or defend any of our intellectual property rights or to defend product liability claims;
|
•
|
the failure of IPI-549, if approved, to achieve commercial success;
|
•
|
the results of clinical trials conducted by others on drugs that would compete with IPI-549;
|
•
|
the regulatory approval of drugs that would compete with IPI-549;
|
•
|
issues in manufacturing IPI-549;
|
•
|
the loss of key employees;
|
•
|
changes in estimates or recommendations, or publication of inaccurate or unfavorable research about our business, by securities analysts who cover our common stock;
|
•
|
future financings through the issuance of equity or debt securities or otherwise;
|
•
|
healthcare reform measures, including changes in the structure of healthcare payment systems;
|
•
|
our cash position and period-to-period fluctuations in our financial results; and
|
•
|
general and industry-specific economic and/or capital market conditions.
|
•
|
delaying, deferring or preventing a change in control of Infinity;
|
•
|
impeding a merger, consolidation, takeover or other business combination involving Infinity; or
|
•
|
discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of Infinity.
|
|
|
2016
|
|
2015
|
||||||||||||
|
|
High
|
|
Low
|
|
High
|
|
Low
|
||||||||
First quarter
|
|
$
|
8.16
|
|
|
$
|
4.75
|
|
|
$
|
17.42
|
|
|
$
|
13.66
|
|
Second quarter
|
|
6.63
|
|
|
1.24
|
|
|
15.44
|
|
|
10.23
|
|
||||
Third quarter
|
|
1.80
|
|
|
1.24
|
|
|
11.13
|
|
|
7.56
|
|
||||
Fourth quarter
|
|
1.65
|
|
|
0.84
|
|
|
10.85
|
|
|
7.19
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Collaboration revenue
|
|
$
|
18,723
|
|
|
$
|
109,066
|
|
|
$
|
164,995
|
|
|
$
|
—
|
|
|
$
|
47,114
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development(1)
|
|
119,611
|
|
|
199,109
|
|
|
143,633
|
|
|
99,760
|
|
|
118,595
|
|
|||||
General and administrative(1)
|
|
42,219
|
|
|
37,065
|
|
|
29,285
|
|
|
27,916
|
|
|
27,882
|
|
|||||
Total operating expenses
|
|
161,830
|
|
|
236,174
|
|
|
172,918
|
|
|
127,676
|
|
|
146,477
|
|
|||||
Gain on AbbVie Opt-Out (2)
|
|
112,216
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Gain on termination of Purdue entities alliance
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46,555
|
|
|||||
Loss from operations
|
|
(30,891
|
)
|
|
(127,108
|
)
|
|
(7,923
|
)
|
|
(127,676
|
)
|
|
(52,808
|
)
|
|||||
Other income (expense), net
|
|
790
|
|
|
(933
|
)
|
|
(9,310
|
)
|
|
896
|
|
|
(1,349
|
)
|
|||||
Income from Massachusetts tax incentive award
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
193
|
|
|||||
Loss before income taxes
|
|
(30,101
|
)
|
|
(128,041
|
)
|
|
(17,233
|
)
|
|
(126,780
|
)
|
|
(53,964
|
)
|
|||||
Income taxes
|
|
—
|
|
|
(335
|
)
|
|
(183
|
)
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
|
$
|
(30,101
|
)
|
|
$
|
(128,376
|
)
|
|
$
|
(17,416
|
)
|
|
$
|
(126,780
|
)
|
|
$
|
(53,964
|
)
|
Basic and diluted loss per common share
|
|
$
|
(0.61
|
)
|
|
$
|
(2.62
|
)
|
|
$
|
(0.36
|
)
|
|
$
|
(2.64
|
)
|
|
$
|
(1.70
|
)
|
Basic and diluted weighted average number of common shares outstanding
|
|
49,608,234
|
|
|
49,083,479
|
|
|
48,561,653
|
|
|
47,936,001
|
|
|
31,711,264
|
|
|
|
As of December 31,
|
||||||||||||||||||
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Selected Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and available-for-sale securities, including long-term
|
|
$
|
92,064
|
|
|
$
|
245,231
|
|
|
$
|
333,245
|
|
|
$
|
214,468
|
|
|
$
|
326,635
|
|
Working capital
|
|
77,797
|
|
|
184,641
|
|
|
289,691
|
|
|
202,735
|
|
|
311,086
|
|
|||||
Total assets
|
|
125,655
|
|
|
288,821
|
|
|
369,144
|
|
|
230,710
|
|
|
335,660
|
|
|||||
Due to Takeda, less current portion(3)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,456
|
|
|
6,252
|
|
|||||
Construction liability(4)
|
|
—
|
|
|
—
|
|
|
15,456
|
|
|
—
|
|
|
—
|
|
|||||
Financing obligation(5)
|
|
19,591
|
|
|
20,007
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Accumulated deficit
|
|
(625,689
|
)
|
|
(595,588
|
)
|
|
(467,212
|
)
|
|
(449,796
|
)
|
|
(323,016
|
)
|
|||||
Total stockholders’ equity
|
|
82,454
|
|
|
98,557
|
|
|
209,472
|
|
|
201,275
|
|
|
310,205
|
|
•
|
compensation of personnel associated with research and development activities;
|
•
|
clinical testing costs, including payments made to contract research organizations;
|
•
|
costs of comparator drugs used in clinical studies;
|
•
|
costs of purchasing laboratory supplies and materials;
|
•
|
costs of manufacturing product candidates for preclinical testing and clinical studies;
|
•
|
costs associated with the licensing of research and development programs;
|
•
|
preclinical testing costs, including costs of toxicology studies;
|
•
|
fees paid to external consultants;
|
•
|
fees paid to professional service providers for independent monitoring and analysis of our clinical trials;
|
•
|
costs for collaboration partners to perform research activities, including development milestones for which a payment is due when achieved;
|
•
|
depreciation of equipment; and
|
•
|
allocated costs of facilities.
|
•
|
the consideration is commensurate with either (1) our performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from our performance to achieve the milestone,
|
•
|
the consideration relates solely to past performance, and
|
•
|
the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
|
|
|
2016
|
|
% Change
|
|
2015
|
|
% Change
|
|
2014
|
||||||||
Collaboration revenue
|
|
$
|
18,723
|
|
|
(83
|
)%
|
|
$
|
109,066
|
|
|
(34
|
)%
|
|
$
|
164,995
|
|
Research and development expense:
|
|
|
|
|
|
|
|
|
|
|
||||||||
Programs
|
|
(119,611
|
)
|
|
(18
|
)%
|
|
(146,609
|
)
|
|
14
|
%
|
|
(128,633
|
)
|
|||
Takeda payments
|
|
—
|
|
|
(100
|
)%
|
|
(52,500
|
)
|
|
250
|
%
|
|
(15,000
|
)
|
|||
Total research and development expense
|
|
(119,611
|
)
|
|
(40
|
)%
|
|
(199,109
|
)
|
|
39
|
%
|
|
(143,633
|
)
|
|||
General and administrative expense
|
|
(42,219
|
)
|
|
14
|
%
|
|
(37,065
|
)
|
|
27
|
%
|
|
(29,285
|
)
|
|||
Gain on AbbVie Opt-Out (note 12)
|
|
112,216
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
|
—
|
|
|||
Interest expense
|
|
(1,225
|
)
|
|
(10
|
)%
|
|
(1,368
|
)
|
|
(86
|
)%
|
|
(9,649
|
)
|
|||
Investment and other income
|
|
2,015
|
|
|
363
|
%
|
|
435
|
|
|
28
|
%
|
|
339
|
|
|||
Income taxes
|
|
—
|
|
|
(100
|
)%
|
|
(335
|
)
|
|
83
|
%
|
|
(183
|
)
|
•
|
$18.7 million of revenue related to development and committee services we performed under our collaboration agreement with AbbVie.
|
•
|
$75.2 million related to license revenue recognized as part of the $130 million enrollment milestone payment received from our collaboration agreement with AbbVie; and
|
•
|
$33.9 million of revenue related to development and committee services we performed under our collaboration agreement with AbbVie.
|
•
|
$159.1 million related to license revenue recognized as part of the $275 million upfront payment received from our collaboration agreement with AbbVie; and
|
•
|
$5.9 million of revenue related to development and committee services we performed under our collaboration agreement with AbbVie.
|
•
|
$52.5 million payment in 2015 to exercise the option purchased from
Takeda Pharmaceutical Company Limited, or Takeda,
in connection with the 2014 amendment of our development and license agreement with Takeda;
|
•
|
$22.0 million decrease in clinical development expenses related to duvelisib,
an oral, dual inhibitor of the delta and gamma isoforms of PI3K
, including charges from AbbVie for costs incurred by AbbVie for other than the AbbVie Studies and for our share of the AbbVie Studies; and
|
•
|
$13.2 million decrease in compensation due to the decrease in headcount resulting from restructuring activities in 2016.
|
•
|
$52.5 million payment to exercise the option purchased from Takeda in connection with the 2014 amendment of our development and license agreement with Takeda;
|
•
|
$10.0 million increase in clinical development expenses related to duvelisib, including charges from AbbVie for costs incurred by AbbVie for other than the AbbVie Studies and for our share of the AbbVie Studies; and
|
•
|
$4.8 million increase in compensation expense primarily due to hiring of additional personnel.
|
Program
|
|
Year Ended
December 31, 2016
|
|
Year Ended
December 31, 2015
|
|
Year Ended
December 31, 2014
|
|
January 1, 2006 to
December 31, 2016
|
||||||||
|
|
(in millions)
|
||||||||||||||
PI3K Inhibitor(1)
|
|
$
|
116.6
|
|
|
$
|
189.6
|
|
|
$
|
120.8
|
|
|
$
|
589.0
|
|
Hsp90 inhibitor
|
|
—
|
|
|
0.1
|
|
|
1.6
|
|
|
137.8
|
|
||||
Hedgehog pathway inhibitor
|
|
—
|
|
|
—
|
|
|
0.1
|
|
|
164.1
|
|
•
|
the nature, timing and estimated costs of the efforts necessary to complete the development of our programs;
|
•
|
the completion dates of these programs; or
|
•
|
the period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future product candidates.
|
•
|
the scope, rate of progress and cost of our clinical trials that we are currently running or may commence in the future;
|
•
|
the scope and rate of progress of our preclinical studies and other research and development activities;
|
•
|
clinical trial results;
|
•
|
the cost of establishing clinical supplies of any product candidates;
|
•
|
the cost and availability of comparator drugs;
|
•
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our programs under development;
|
•
|
the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our programs under development;
|
•
|
the cost and timing of regulatory approvals; and
|
•
|
the effect of competing technological and market developments.
|
|
|
December 31, 2016
|
|
December 31, 2015
|
||||
|
|
(in thousands)
|
||||||
Cash, cash equivalents and available-for-sale securities
|
|
$
|
92,064
|
|
|
$
|
245,231
|
|
Working capital
|
|
77,797
|
|
|
184,641
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
(in thousands)
|
||||||||||
Cash (used in) provided by:
|
|
|
|
|
|
|
||||||
Operating activities
|
|
$
|
(154,356
|
)
|
|
$
|
(83,653
|
)
|
|
$
|
117,715
|
|
Takeda payments (included in operating activities above)
|
|
—
|
|
|
(59,167
|
)
|
|
(21,667
|
)
|
|||
Investing activities
|
|
40,329
|
|
|
(37,903
|
)
|
|
117,853
|
|
|||
Capital expenditures (included in investing activities above)
|
|
(661
|
)
|
|
(6,426
|
)
|
|
(1,362
|
)
|
|||
Financing activities
|
|
(83
|
)
|
|
2,321
|
|
|
3,723
|
|
•
|
our product candidates require more extensive clinical or preclinical testing than we currently expect;
|
•
|
we advance our product candidates into clinical trials for more indications than we currently expect;
|
•
|
we advance more of our product candidates than expected into costly later stage clinical trials;
|
•
|
we advance more preclinical product candidates than expected into early stage clinical trials;
|
•
|
we acquire additional business, technologies, products or product candidates;
|
•
|
the cost of acquiring raw materials for, and of manufacturing, our product candidates is higher than anticipated;
|
•
|
the cost or quantity required of comparator drugs used in clinical studies increases;
|
•
|
we are required, or consider it advisable, to acquire or license intellectual property rights from one or more third parties; or
|
•
|
we experience a loss in our investments due to general market conditions or other reasons.
|
|
Charges incurred during the year ended December 31, 2016
|
|
Amounts paid through December 31, 2016
|
|
Less non-cash charges during the year ended December 31, 2016
|
|
Amounts accrued at December 31, 2016
|
||||||||
|
(in thousands)
|
||||||||||||||
Employee severance, benefits and related costs for work force reduction
|
$
|
17,960
|
|
|
$
|
9,516
|
|
|
$
|
1,552
|
|
|
$
|
6,892
|
|
Long-lived asset impairment
|
1,324
|
|
|
—
|
|
|
1,324
|
|
|
—
|
|
||||
Contract termination, prepaid expense write-offs and other related costs
|
1,891
|
|
|
821
|
|
|
1,042
|
|
|
28
|
|
||||
Total restructuring
|
$
|
21,175
|
|
|
$
|
10,337
|
|
|
$
|
3,918
|
|
|
$
|
6,920
|
|
|
|
Payments Due by Period
|
||||||||||||||||||||||||||
|
|
(in thousands)
|
||||||||||||||||||||||||||
Contractual Obligations
|
|
Total
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
and beyond
|
||||||||||||||
784 facility
|
|
$
|
18,079
|
|
|
$
|
2,044
|
|
|
$
|
2,044
|
|
|
$
|
2,044
|
|
|
$
|
2,227
|
|
|
$
|
2,287
|
|
|
$
|
7,433
|
|
Total contractual cash obligations
|
|
$
|
18,079
|
|
|
$
|
2,044
|
|
|
$
|
2,044
|
|
|
$
|
2,044
|
|
|
$
|
2,227
|
|
|
$
|
2,287
|
|
|
$
|
7,433
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
74,060
|
|
|
$
|
188,170
|
|
Available-for-sale securities
|
18,004
|
|
|
57,061
|
|
||
Restricted cash
|
1,152
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
8,444
|
|
|
9,466
|
|
||
Total current assets
|
101,660
|
|
|
254,697
|
|
||
Property and equipment, net
|
23,424
|
|
|
28,240
|
|
||
Restricted cash, less current portion
|
530
|
|
|
1,681
|
|
||
Long-term receivable (note 11)
|
—
|
|
|
1,821
|
|
||
Other assets
|
41
|
|
|
2,382
|
|
||
Total assets
|
$
|
125,655
|
|
|
$
|
288,821
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
2,413
|
|
|
$
|
9,628
|
|
Accrued expenses
|
21,008
|
|
|
24,604
|
|
||
Deferred revenue, current
|
—
|
|
|
35,408
|
|
||
Financing obligation, current (note 11)
|
442
|
|
|
416
|
|
||
Total current liabilities
|
23,863
|
|
|
70,056
|
|
||
Deferred revenue, less current portion
|
—
|
|
|
95,531
|
|
||
Deferred rent, less current portion (note 11)
|
183
|
|
|
4,632
|
|
||
Financing obligation, less current portion (note 11)
|
19,149
|
|
|
19,591
|
|
||
Other liabilities
|
6
|
|
|
454
|
|
||
Total liabilities
|
43,201
|
|
|
190,264
|
|
||
Commitments and contingencies (note 11)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred Stock, $0.001 par value; 1,000,000 shares authorized, no shares issued and outstanding at December 31, 2016 and 2015
|
—
|
|
|
—
|
|
||
Common Stock, $0.001 par value; 100,000,000 shares authorized, 50,374,871 and 49,305,136 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively
|
50
|
|
|
49
|
|
||
Additional paid-in capital
|
708,096
|
|
|
694,051
|
|
||
Accumulated deficit
|
(625,689
|
)
|
|
(595,588
|
)
|
||
Accumulated other comprehensive income (loss)
|
(3
|
)
|
|
45
|
|
||
Total stockholders’ equity
|
82,454
|
|
|
98,557
|
|
||
Total liabilities and stockholders’ equity
|
$
|
125,655
|
|
|
$
|
288,821
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Collaboration revenue
|
$
|
18,723
|
|
|
$
|
109,066
|
|
|
$
|
164,995
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
119,611
|
|
|
199,109
|
|
|
143,633
|
|
|||
General and administrative
|
42,219
|
|
|
37,065
|
|
|
29,285
|
|
|||
Total operating expenses
|
161,830
|
|
|
236,174
|
|
|
172,918
|
|
|||
Gain on AbbVie Opt-Out (note 12)
|
112,216
|
|
|
—
|
|
|
—
|
|
|||
Loss from operations
|
(30,891
|
)
|
|
(127,108
|
)
|
|
(7,923
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest expense
|
(1,225
|
)
|
|
(1,368
|
)
|
|
(9,649
|
)
|
|||
Investment and other income
|
2,015
|
|
|
435
|
|
|
339
|
|
|||
Total other income (expense)
|
790
|
|
|
(933
|
)
|
|
(9,310
|
)
|
|||
Loss before income taxes
|
(30,101
|
)
|
|
(128,041
|
)
|
|
(17,233
|
)
|
|||
Income taxes
|
—
|
|
|
(335
|
)
|
|
(183
|
)
|
|||
Net loss
|
$
|
(30,101
|
)
|
|
$
|
(128,376
|
)
|
|
$
|
(17,416
|
)
|
Basic and diluted loss per common share
|
$
|
(0.61
|
)
|
|
$
|
(2.62
|
)
|
|
$
|
(0.36
|
)
|
Basic and diluted weighted average number of common shares outstanding
|
49,608,234
|
|
|
49,083,479
|
|
|
48,561,653
|
|
|||
Other comprehensive loss:
|
|
|
|
|
|
||||||
Net unrealized holding losses on available-for-sale securities arising during the period
|
$
|
(48
|
)
|
|
$
|
(69
|
)
|
|
$
|
(42
|
)
|
Comprehensive loss
|
$
|
(30,149
|
)
|
|
$
|
(128,445
|
)
|
|
$
|
(17,458
|
)
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(30,101
|
)
|
|
$
|
(128,376
|
)
|
|
$
|
(17,416
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||||||
Non-cash gain on AbbVie Opt-Out (note 12)
|
(112,216
|
)
|
|
—
|
|
|
—
|
|
|||
Depreciation
|
3,418
|
|
|
2,292
|
|
|
1,773
|
|
|||
Stock-based compensation, including 401(k) match
|
13,714
|
|
|
14,700
|
|
|
12,588
|
|
|||
Impairment of property and equipment
|
771
|
|
|
—
|
|
|
—
|
|
|||
Gain on sale of fixed assets
|
(876
|
)
|
|
—
|
|
|
—
|
|
|||
Non-cash interest expense on amount Due to Takeda
|
—
|
|
|
—
|
|
|
211
|
|
|||
Amortization of loan commitment asset
|
—
|
|
|
647
|
|
|
9,649
|
|
|||
Net amortization of premium/discount on available-for-sale securities
|
159
|
|
|
272
|
|
|
1,257
|
|
|||
Other, net
|
(2
|
)
|
|
(162
|
)
|
|
83
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Prepaid expenses and other assets
|
5,208
|
|
|
933
|
|
|
(494
|
)
|
|||
Accounts payable, accrued expenses and other liabilities
|
(20,418
|
)
|
|
10,517
|
|
|
6,815
|
|
|||
Due to Takeda
|
—
|
|
|
(6,667
|
)
|
|
(6,667
|
)
|
|||
Deferred revenue
|
(18,723
|
)
|
|
20,934
|
|
|
110,005
|
|
|||
Deferred rent
|
4,710
|
|
|
1,257
|
|
|
(89
|
)
|
|||
Net cash provided by (used in) operating activities
|
(154,356
|
)
|
|
(83,653
|
)
|
|
117,715
|
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(661
|
)
|
|
(6,426
|
)
|
|
(1,362
|
)
|
|||
Proceeds from sale of assets
|
2,140
|
|
|
—
|
|
|
—
|
|
|||
Purchases of available-for-sale securities
|
(66,503
|
)
|
|
(121,456
|
)
|
|
(21,789
|
)
|
|||
Proceeds from maturities of available-for-sale securities
|
93,400
|
|
|
89,515
|
|
|
141,004
|
|
|||
Proceeds from sales of available-for-sale securities
|
11,953
|
|
|
464
|
|
|
—
|
|
|||
Net cash provided by (used in) investing activities
|
40,329
|
|
|
(37,903
|
)
|
|
117,853
|
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from issuances of common stock related to stock incentive plans, net
|
314
|
|
|
1,866
|
|
|
3,881
|
|
|||
Proceeds from issuances of common stock related to employee stock purchase plan
|
18
|
|
|
964
|
|
|
836
|
|
|||
Payments on construction liability
|
—
|
|
|
(273
|
)
|
|
—
|
|
|||
Payments on financing obligation
|
(415
|
)
|
|
(236
|
)
|
|
—
|
|
|||
Restricted cash
|
—
|
|
|
—
|
|
|
(548
|
)
|
|||
Deferred transaction costs
|
—
|
|
|
—
|
|
|
(446
|
)
|
|||
Net cash provided by (used in) financing activities
|
(83
|
)
|
|
2,321
|
|
|
3,723
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
(114,110
|
)
|
|
(119,235
|
)
|
|
239,291
|
|
|||
Cash and cash equivalents at beginning of period
|
188,170
|
|
|
307,405
|
|
|
68,114
|
|
|||
Cash and cash equivalents at end of period
|
$
|
74,060
|
|
|
$
|
188,170
|
|
|
$
|
307,405
|
|
Supplemental cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
1,225
|
|
|
$
|
721
|
|
|
$
|
—
|
|
Cash paid for income taxes
|
$
|
5
|
|
|
$
|
885
|
|
|
$
|
—
|
|
Supplemental schedule of noncash investing and financing activities
|
|
|
|
|
|
||||||
Loan commitment asset
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
9,850
|
|
Facility fee
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,500
|
|
Warrants issued
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,350
|
|
Construction liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,456
|
|
Reclassification to financing obligation
|
$
|
—
|
|
|
$
|
19,273
|
|
|
$
|
—
|
|
Property and equipment in accrued expenses
|
$
|
—
|
|
|
$
|
65
|
|
|
$
|
—
|
|
Increase in property and equipment for amount paid by landlord
|
$
|
—
|
|
|
$
|
5,059
|
|
|
$
|
797
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Total
Stockholders’ Equity |
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance at December 31, 2013
|
48,227,838
|
|
|
$
|
48
|
|
|
$
|
650,867
|
|
|
$
|
(449,796
|
)
|
|
$
|
156
|
|
|
$
|
201,275
|
|
Exercise of stock options
|
523,954
|
|
|
|
|
3,881
|
|
|
|
|
|
|
3,881
|
|
||||||||
Valuation of initial warrants
|
|
|
|
|
8,350
|
|
|
|
|
|
|
8,350
|
|
|||||||||
Stock-based compensation expense
|
|
|
|
|
11,878
|
|
|
|
|
|
|
11,878
|
|
|||||||||
401(k) plan match issued in common stock
|
50,464
|
|
|
|
|
710
|
|
|
|
|
|
|
710
|
|
||||||||
Issuance of common stock related to employee stock purchase plan
|
76,572
|
|
|
1
|
|
|
835
|
|
|
|
|
|
|
836
|
|
|||||||
Unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
(42
|
)
|
|
(42
|
)
|
|||||||||
Net loss
|
|
|
|
|
|
|
(17,416
|
)
|
|
|
|
(17,416
|
)
|
|||||||||
Balance at December 31, 2014
|
48,878,828
|
|
|
$
|
49
|
|
|
$
|
676,521
|
|
|
$
|
(467,212
|
)
|
|
$
|
114
|
|
|
$
|
209,472
|
|
Exercise of stock options
|
225,578
|
|
|
|
|
1,796
|
|
|
|
|
|
|
1,796
|
|
||||||||
Stock-based compensation expense
|
|
|
|
|
13,844
|
|
|
|
|
|
|
13,844
|
|
|||||||||
401(k) plan match issued in common stock
|
68,235
|
|
|
|
|
856
|
|
|
|
|
|
|
856
|
|
||||||||
Issuance of common stock related to employee stock purchase plan
|
124,358
|
|
|
|
|
964
|
|
|
|
|
|
|
964
|
|
||||||||
Issuance of common stock for services
|
8,137
|
|
|
|
|
70
|
|
|
|
|
|
|
70
|
|
||||||||
Unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
(69
|
)
|
|
(69
|
)
|
|||||||||
Net loss
|
|
|
|
|
|
|
(128,376
|
)
|
|
|
|
(128,376
|
)
|
|||||||||
Balance at December 31, 2015
|
49,305,136
|
|
|
$
|
49
|
|
|
$
|
694,051
|
|
|
$
|
(595,588
|
)
|
|
$
|
45
|
|
|
$
|
98,557
|
|
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Total
Stockholders’
Equity
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance at December 31, 2015
|
|
49,305,136
|
|
|
$
|
49
|
|
|
$
|
694,051
|
|
|
$
|
(595,588
|
)
|
|
$
|
45
|
|
|
$
|
98,557
|
|
Exercise of stock options
|
|
67,077
|
|
|
|
|
373
|
|
|
|
|
|
|
373
|
|
||||||||
Stock-based compensation expense
|
|
|
|
|
|
11,937
|
|
|
|
|
|
|
11,937
|
|
|||||||||
401(k) plan match issued in common stock
|
|
295,596
|
|
|
|
|
619
|
|
|
|
|
|
|
619
|
|
||||||||
Issuance of common stock related to employee stock purchase plan
|
|
15,860
|
|
|
|
|
18
|
|
|
|
|
|
|
18
|
|
||||||||
Vesting of restricted stock and other, net
|
|
691,202
|
|
|
1
|
|
|
1,098
|
|
|
|
|
|
|
1,099
|
|
|||||||
Unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
|
(48
|
)
|
|
(48
|
)
|
|||||||||
Net loss
|
|
|
|
|
|
|
|
(30,101
|
)
|
|
|
|
(30,101
|
)
|
|||||||||
Balance at December 31, 2016
|
|
50,374,871
|
|
|
$
|
50
|
|
|
$
|
708,096
|
|
|
$
|
(625,689
|
)
|
|
$
|
(3
|
)
|
|
$
|
82,454
|
|
Laboratory equipment
|
|
5 years
|
Computer equipment and software
|
|
3 to 5 years
|
Leasehold improvements
|
|
Shorter of lease term or useful life of asset
|
Building and building improvements
|
|
10 to 50 years, less estimated residual
value at the end of the financing obligation term |
Furniture and fixtures
|
|
7 to 10 years
|
•
|
the consideration is commensurate with either (1) our performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from our performance to achieve the milestone,
|
•
|
the consideration relates solely to past performance, and
|
•
|
the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
|
|
At December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Stock options
|
6,067,945
|
|
|
8,265,577
|
|
|
6,577,296
|
|
Warrants
|
1,000,000
|
|
|
1,000,000
|
|
|
1,000,000
|
|
Unvested restricted stock
|
797,111
|
|
|
—
|
|
|
—
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
(in thousands)
|
||||||||||
Research and development
|
$
|
6,421
|
|
|
$
|
8,474
|
|
|
$
|
7,502
|
|
General and administrative
|
7,293
|
|
|
6,226
|
|
|
5,086
|
|
|||
Total stock-based compensation expense
|
$
|
13,714
|
|
|
$
|
14,700
|
|
|
$
|
12,588
|
|
|
December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Risk-free interest rate
|
1.8
|
%
|
|
1.5
|
%
|
|
1.7
|
%
|
Expected annual dividend yield
|
—
|
|
|
—
|
|
|
—
|
|
Expected stock price volatility
|
73.0
|
%
|
|
70.8
|
%
|
|
70.9
|
%
|
Expected term of options
|
5.4 years
|
|
|
5.4 years
|
|
|
5.0 years
|
|
•
|
Risk-free interest rate:
The yield on zero-coupon U.S. Treasury securities for a period that was commensurate with the expected term of the awards.
|
•
|
Expected annual dividend yield:
The estimate for annual dividends was zero, because we have not historically paid a dividend and do not intend to do so in the foreseeable future.
|
•
|
Expected stock price volatility:
We determined the expected volatility by using our available implied and historical price information.
|
•
|
Expected term of options:
The expected term of the awards represents the period of time that the awards were expected to be outstanding. We used historical data and expectations for the future to estimate employee exercise and post-vest termination behavior.
|
|
Stock Options
|
|
Weighted-
Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual Life
(years)
|
|
Aggregate
Intrinsic Value
(in millions)
|
|||||
Outstanding at January 1, 2016
|
8,265,577
|
|
|
$
|
13.73
|
|
|
|
|
|
||
Granted
|
1,617,472
|
|
|
6.14
|
|
|
|
|
|
|||
Exercised
|
(67,077
|
)
|
|
6.40
|
|
|
|
|
|
|||
Forfeited
|
(3,748,027
|
)
|
|
13.31
|
|
|
|
|
|
|||
Outstanding at December 31, 2016
|
6,067,945
|
|
|
$
|
12.06
|
|
|
3.6
|
|
$
|
—
|
|
Vested or expected to vest at December 31, 2016
|
5,883,619
|
|
|
$
|
12.13
|
|
|
3.5
|
|
$
|
—
|
|
Exercisable at December 31, 2016
|
4,795,643
|
|
|
$
|
12.46
|
|
|
3.2
|
|
$
|
—
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Risk-free interest rate
|
0.8
|
%
|
|
0.4
|
%
|
|
0.3
|
%
|
Expected annual dividend yield
|
—
|
|
|
—
|
|
|
—
|
|
Expected stock price volatility
|
63.5
|
%
|
|
60.3
|
%
|
|
66.7
|
%
|
Expected term of options
|
1.25 years
|
|
|
1.25 years
|
|
|
1.25 years
|
|
|
December 31, 2016
|
||||||||||||||
|
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
Cash and cash equivalents
|
$
|
74,060
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
74,060
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. Treasury securities due in one year or less
|
6,753
|
|
|
—
|
|
|
(1
|
)
|
|
6,752
|
|
||||
U.S. government-sponsored enterprise obligations due in one year or less
|
11,254
|
|
|
—
|
|
|
(2
|
)
|
|
11,252
|
|
||||
Total available-for-sale securities
|
18,007
|
|
|
—
|
|
|
(3
|
)
|
|
18,004
|
|
||||
Total cash, cash equivalents and available-for-sale securities
|
$
|
92,067
|
|
|
$
|
—
|
|
|
$
|
(3
|
)
|
|
$
|
92,064
|
|
|
|
|
|
|
|
|
|
||||||||
|
December 31, 2015
|
||||||||||||||
|
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
|
(in thousands)
|
||||||||||||||
Cash and cash equivalents
|
$
|
188,170
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
188,170
|
|
Available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Corporate obligations due in one year or less
|
46,049
|
|
|
52
|
|
|
(4
|
)
|
|
46,097
|
|
||||
Asset-backed securities due in one year or less
|
10,967
|
|
|
—
|
|
|
(3
|
)
|
|
10,964
|
|
||||
Total available-for-sale securities
|
57,016
|
|
|
52
|
|
|
(7
|
)
|
|
57,061
|
|
||||
Total cash, cash equivalents and available-for-sale securities
|
$
|
245,186
|
|
|
$
|
52
|
|
|
$
|
(7
|
)
|
|
$
|
245,231
|
|
|
Level 1
|
|
Level 2
|
||||
|
(in thousands)
|
||||||
Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
61,008
|
|
|
$
|
13,052
|
|
U.S. Treasury securities
|
—
|
|
|
6,752
|
|
||
U.S. government-sponsored enterprise obligations
|
—
|
|
|
11,252
|
|
||
Total
|
$
|
61,008
|
|
|
$
|
31,056
|
|
•
|
U.S. Treasury securities
: benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including TRACE
®
reported trades.
|
•
|
U.S. government-sponsored enterprise obligations
: benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including TRACE
®
reported trades.
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Prepaid expenses
|
$
|
3,336
|
|
|
$
|
6,898
|
|
Other current assets
|
5,023
|
|
|
1,383
|
|
||
Short-term receivable (note 11)
|
—
|
|
|
1,185
|
|
||
Value-added tax
|
85
|
|
|
—
|
|
||
Total prepaid expenses and other current assets
|
$
|
8,444
|
|
|
$
|
9,466
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Laboratory equipment
|
$
|
—
|
|
|
$
|
12,190
|
|
Computer equipment and software
|
4,411
|
|
|
5,704
|
|
||
Furniture and fixtures
|
918
|
|
|
2,136
|
|
||
Building and building improvements
|
23,586
|
|
|
23,586
|
|
||
Leasehold improvements
|
431
|
|
|
5,533
|
|
||
|
29,346
|
|
|
49,149
|
|
||
Less accumulated depreciation
|
(5,922
|
)
|
|
(20,909
|
)
|
||
|
$
|
23,424
|
|
|
$
|
28,240
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Value-added tax, net
|
$
|
—
|
|
|
$
|
2,034
|
|
Long term prepaid expenses
|
22
|
|
|
284
|
|
||
Other assets
|
19
|
|
|
64
|
|
||
Total other assets
|
$
|
41
|
|
|
$
|
2,382
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Accrued restructuring
|
$
|
6,920
|
|
|
$
|
—
|
|
Accrued compensation and benefits
|
5,445
|
|
|
8,732
|
|
||
Accrued drug manufacturing costs
|
311
|
|
|
3,494
|
|
||
Accrued clinical studies
|
7,054
|
|
|
8,531
|
|
||
Accrued preclinical studies
|
2
|
|
|
539
|
|
||
Deferred rent, current
|
—
|
|
|
261
|
|
||
Other
|
1,276
|
|
|
3,047
|
|
||
Total accrued expenses
|
$
|
21,008
|
|
|
$
|
24,604
|
|
|
784 Facility
|
||
|
(in thousands)
|
||
Years Ending December 31:
|
|
||
2017
|
$
|
2,044
|
|
2018
|
2,044
|
|
|
2019
|
2,044
|
|
|
2020
|
2,227
|
|
|
2021
|
2,287
|
|
|
2022 and beyond
|
7,433
|
|
|
Total minimum lease payments
|
$
|
18,079
|
|
|
Charges incurred during the year ended December 31, 2016
|
|
Amounts paid through December 31, 2016
|
|
Less non-cash charges during the year ended December 31, 2016
|
|
Amounts accrued at December 31, 2016
|
||||||||
|
(in thousands)
|
||||||||||||||
Employee severance, benefits and related costs for work force reduction
|
$
|
17,960
|
|
|
$
|
9,516
|
|
|
$
|
1,552
|
|
|
$
|
6,892
|
|
Long-lived asset impairment
|
1,324
|
|
|
—
|
|
|
1,324
|
|
|
—
|
|
||||
Contract termination, prepaid expense write-offs and other related costs
|
1,891
|
|
|
821
|
|
|
1,042
|
|
|
28
|
|
||||
Total restructuring
|
$
|
21,175
|
|
|
$
|
10,337
|
|
|
$
|
3,918
|
|
|
$
|
6,920
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
(in thousands)
|
||||||||||
Expected federal tax benefit
|
$
|
(10,234
|
)
|
|
$
|
(43,534
|
)
|
|
$
|
(5,872
|
)
|
Permanent differences
|
1,749
|
|
|
2,263
|
|
|
3,537
|
|
|||
State taxes, net of the deferred federal benefit
|
(1,589
|
)
|
|
(6,762
|
)
|
|
(912
|
)
|
|||
Tax credit carryforwards
|
(37
|
)
|
|
(2,735
|
)
|
|
(9,510
|
)
|
|||
Adjustments to deferred tax assets and deferred tax liabilities
|
121
|
|
|
(1,267
|
)
|
|
776
|
|
|||
Alternative minimum tax
|
—
|
|
|
321
|
|
|
183
|
|
|||
Other
|
79
|
|
|
29
|
|
|
79
|
|
|||
Change in valuation allowance
|
9,911
|
|
|
52,020
|
|
|
11,902
|
|
|||
Income tax expense
|
$
|
—
|
|
|
$
|
335
|
|
|
$
|
183
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Deferred tax assets (liabilities):
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
178,125
|
|
|
$
|
128,851
|
|
Tax credit carryforwards
|
40,051
|
|
|
40,014
|
|
||
Deferred revenue
|
—
|
|
|
34,924
|
|
||
Intangible assets
|
32,199
|
|
|
34,710
|
|
||
Accrued expenses
|
822
|
|
|
3,003
|
|
||
Stock-based compensation
|
11,974
|
|
|
12,172
|
|
||
Other
|
(377
|
)
|
|
(794
|
)
|
||
Valuation allowance
|
(262,794
|
)
|
|
(252,880
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Quarter Ended
March 31, 2016
|
|
Quarter Ended
June 30, 2016
|
|
Quarter Ended
September 30, 2016
|
|
Quarter Ended
December 31, 2016
|
||||||||
|
(in thousands, except shares and per share amounts)
|
||||||||||||||
Collaboration revenue
|
$
|
9,256
|
|
|
$
|
9,467
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
39,188
|
|
|
52,947
|
|
|
12,814
|
|
|
14,662
|
|
||||
General and administrative
|
10,836
|
|
|
15,692
|
|
|
7,120
|
|
|
8,571
|
|
||||
Total operating expenses
|
50,024
|
|
|
68,639
|
|
|
19,934
|
|
|
23,233
|
|
||||
Gain on AbbVie Opt-Out (note 12)
|
—
|
|
|
112,216
|
|
|
—
|
|
|
—
|
|
||||
Income (loss) from operations
|
(40,768
|
)
|
|
53,044
|
|
|
(19,934
|
)
|
|
(23,233
|
)
|
||||
Other income (expenses):
|
|
|
|
|
|
|
|
||||||||
Interest expense
|
(309
|
)
|
|
(307
|
)
|
|
(305
|
)
|
|
(304
|
)
|
||||
Investment and other income
|
413
|
|
|
254
|
|
|
741
|
|
|
607
|
|
||||
Total other income (expense)
|
104
|
|
|
(53
|
)
|
|
436
|
|
|
303
|
|
||||
Income (loss) before income taxes
|
(40,664
|
)
|
|
52,991
|
|
|
(19,498
|
)
|
|
(22,930
|
)
|
||||
Income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Net income (loss)
|
$
|
(40,664
|
)
|
|
$
|
52,991
|
|
|
$
|
(19,498
|
)
|
|
$
|
(22,930
|
)
|
Income (loss) per common share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.82
|
)
|
|
$
|
1.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(0.46
|
)
|
Diluted
|
$
|
(0.82
|
)
|
|
$
|
1.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(0.46
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
49,339,888
|
|
|
49,437,062
|
|
|
49,583,776
|
|
|
50,099,153
|
|
||||
Diluted
|
49,339,888
|
|
|
49,439,537
|
|
|
49,583,776
|
|
|
50,099,153
|
|
||||
|
|
|
|
|
|
|
|
||||||||
|
Quarter Ended
March 31, 2015
|
|
Quarter Ended
June 30, 2015
|
|
Quarter Ended
September 30, 2015
|
|
Quarter Ended
December 31, 2015
|
||||||||
|
(in thousands, except shares and per share amounts)
|
||||||||||||||
Collaboration revenue
|
$
|
4,363
|
|
|
$
|
4,880
|
|
|
$
|
90,743
|
|
|
$
|
9,080
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
88,428
|
|
|
34,062
|
|
|
37,729
|
|
|
38,890
|
|
||||
General and administrative
|
8,550
|
|
|
9,410
|
|
|
9,754
|
|
|
9,351
|
|
||||
Total operating expenses
|
96,978
|
|
|
43,472
|
|
|
47,483
|
|
|
48,241
|
|
||||
Income (loss) from operations
|
(92,615
|
)
|
|
(38,592
|
)
|
|
43,260
|
|
|
(39,161
|
)
|
||||
Other income (expenses):
|
|
|
|
|
|
|
|
||||||||
Interest expense
|
(647
|
)
|
|
(99
|
)
|
|
(311
|
)
|
|
(311
|
)
|
||||
Interest and investment income (loss)
|
(40
|
)
|
|
263
|
|
|
75
|
|
|
137
|
|
||||
Total other income (expense)
|
(687
|
)
|
|
164
|
|
|
(236
|
)
|
|
(174
|
)
|
||||
Income (loss) before income taxes
|
(93,302
|
)
|
|
(38,428
|
)
|
|
43,024
|
|
|
(39,335
|
)
|
||||
Income taxes
|
—
|
|
|
—
|
|
|
(480
|
)
|
|
145
|
|
||||
Net income (loss)
|
$
|
(93,302
|
)
|
|
$
|
(38,428
|
)
|
|
$
|
42,544
|
|
|
$
|
(39,190
|
)
|
Income (loss) per common share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(1.91
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
0.85
|
|
|
$
|
(0.80
|
)
|
Diluted
|
$
|
(1.91
|
)
|
|
$
|
(0.78
|
)
|
|
$
|
0.84
|
|
|
$
|
(0.80
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
48,939,383
|
|
|
49,076,031
|
|
|
49,188,443
|
|
|
49,227,905
|
|
Diluted
|
48,939,383
|
|
|
49,076,031
|
|
|
49,764,910
|
|
|
49,227,905
|
|
•
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
|
•
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
|
•
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
|
|
|
|
Page number
|
|
INFINITY PHARMACEUTICALS, INC.
|
|
|
|
|
Date: March 14, 2017
|
By:
|
/s/ A
DELENE
Q. P
ERKINS
|
|
|
Adelene Q. Perkins
Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ A
DELENE
Q. P
ERKINS
Adelene Q. Perkins
|
|
Chief Executive Officer; Chair of the Board of Directors
|
|
March 14, 2017
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
||
/s/ L
AWRENCE
E. B
LOCH
, M.D., J.D.
Lawrence E. Bloch, M.D., J.D.
|
|
President; Treasurer
|
|
March 14, 2017
|
|
|
(Principal Financial Officer, Principal Accounting Officer)
|
|
|
|
|
|
||
/s/ J
OSÉ
B
ASELGA
, M.D., P
H
.D.
José Baselga, M.D., Ph.D.
|
|
Director
|
|
March 7, 2017
|
|
|
|
||
/s/ J
EFFREY
B
ERKOWITZ
, J.D.
Jeffrey Berkowitz, J.D.
|
|
Director
|
|
March 10, 2017
|
|
|
|
||
/s/ A
NTHONY
B. E
VNIN
, P
H
.D.
Anthony B. Evnin, Ph.D.
|
|
Director
|
|
March 9, 2017
|
|
|
|
||
/s/ N
ORMAN
C. S
ELBY
Norman C. Selby
|
|
Director
|
|
March 14, 2017
|
|
|
|
||
/s/ I
AN
F. S
MITH
Ian F. Smith
|
|
Director
|
|
March 7, 2017
|
|
|
|
||
/s/ M
ICHAEL
C. V
ENUTI
, P
H
.D.
Michael C. Venuti, Ph.D.
|
|
Director
|
|
March 14, 2017
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
3.1
|
|
Restated Certificate of Incorporation of the Registrant.
|
|
10-Q
|
|
8/9/2007
|
|
3.1
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Registrant.
|
|
8-K
|
|
3/17/2009
|
|
3.1
|
|
|
|
4.1
|
|
Form of Common Stock Certificate.
|
|
10-K
|
|
3/14/2008
|
|
4.1
|
|
|
|
Collaboration Agreements
|
|
|
|
|
|
|
|
|
|||
10.1†
|
|
Amended and Restated Development and License Agreement, dated as of December 24, 2012, by and between the Registrant and Intellikine, LLC.
|
|
10-K
|
|
3/5/2013
|
|
10.4
|
|
|
|
10.2
|
|
Amendment to Amended and Restated Development and License Agreement, dated as of dated July 29, 2014, by and between Infinity Pharmaceuticals, Inc. and Intellikine LLC.
|
|
10-Q
|
|
11/10/2014
|
|
10.1
|
|
|
|
10.3
|
|
Amendment No. 2 to Amended and Restated Development and License Agreement, dated as of dated September 27, 2016, by and between Infinity Pharmaceuticals, Inc. and Intellikine LLC.
|
|
10-Q
|
|
11/9/2016
|
|
10.1
|
|
|
|
10.4†
|
|
Amended and Restated License Agreement, dated as of November 1, 2016, by and between the Registrant and Verastem, Inc.
|
|
|
|
|
|
|
|
X
|
|
10.5
|
|
Termination and Revised Relationship Agreement, dated as of July 17, 2012, between the Registrant and Mundipharma International Corporation Limited.
|
|
8-K
|
|
7/19/2012
|
|
10.2
|
|
|
|
10.6
|
|
Termination and Revised Relationship Agreement, dated as of July 17, 2012, between the Registrant and Purdue Pharmaceutical Products L.P.
|
|
8-K
|
|
7/19/2012
|
|
10.3
|
|
|
|
Financing Agreements
|
|
|
|
|
|
|
|
|
|||
10.7
|
|
Form of Warrant to Purchase Common Stock of Infinity Pharmaceuticals, Inc., issued to the Deerfield Entities, together with a schedule of holders and amounts (issued February 24, 2014).
|
|
10-Q
|
|
5/6/2014
|
|
10.2
|
|
|
|
Leases
|
|
|
|
|
|
|
|
|
|||
10.8
|
|
Lease Agreement, dated as of September 25, 2014, between Infinity Pharmaceuticals, Inc. and BHX, LLC, as trustee of 784 Realty Trust.
|
|
10-Q
|
|
11/10/2014
|
|
10.4
|
|
|
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
10.9
|
|
Lease Agreement dated July 2, 2002 between IDI and ARE-770/784/790 Memorial Drive LLC (the “Lease”), as amended by First Amendment to Lease dated March 25, 2003, Second Amendment to Lease dated April 30, 2003, Third Amendment to Lease dated October 30, 2003 and Fourth Amendment to Lease dated December 15, 2003.
|
|
8-K
|
|
9/18/2006
|
|
10.36
|
|
|
|
10.10
|
|
Fifth Amendment to Lease dated July 8, 2011 between the Registrant and ARE-770/784/790 Memorial Drive LLC.
|
|
10-Q
|
|
8/9/2011
|
|
10.1
|
|
|
|
10.11
|
|
Sixth Amendment to Lease dated July 8, 2012 between the Registrant and ARE-770/784/790 Memorial Drive LLC.
|
|
10-Q
|
|
8/7/2012
|
|
10.2
|
|
|
|
10.12
|
|
Seventh Amendment to Lease, dated as of November 6, 2014, between Infinity Pharmaceuticals, Inc. and ARE-770/784/790 Memorial Drive, LLC.
|
|
10-Q
|
|
11/10/2014
|
|
10.5
|
|
|
|
10.13
|
|
Agreement for Termination of Lease and Voluntary Surrender of Premises dated October 31, 2016 between the Registrant and ARE-770/784/790 Memorial Drive, LLC
|
|
|
|
|
|
|
|
X
|
|
Equity Plans
|
|||||||||||
10.14*
|
|
2000 Stock Incentive Plan.
|
|
S-1
|
|
5/9/2000
|
|
10.59
|
|
|
|
10.15*
|
|
Amendment No. 1 to 2000 Stock Incentive Plan;
Amendment No. 2 to 2000 Stock Incentive Plan;
Amendment No. 3 to 2000 Stock Incentive Plan.
|
|
8-K
|
|
9/18/2006
|
|
10.32
|
|
|
|
10.16*
|
|
Amendment No. 4 to 2000 Stock Incentive Plan.
|
|
10-Q
|
|
8/9/2007
|
|
10.1
|
|
|
|
10.17*
|
|
Amendment No. 5 to 2000 Stock Incentive Plan.
|
|
S-8
|
|
5/23/2008
|
|
99.4
|
|
|
|
10.18*
|
|
Form of Incentive Stock Option Agreement under 2000 Stock Incentive Plan.
|
|
8-K
|
|
9/18/2006
|
|
10.33
|
|
|
|
10.19*
|
|
Form of Nonstatutory Stock Option Agreement under 2000 Stock Incentive Plan.
|
|
8-K
|
|
9/18/2006
|
|
10.34
|
|
|
|
10.20*
|
|
2010 Stock Incentive Plan.
|
|
8-K
|
|
5/28/2010
|
|
10.1
|
|
|
|
10.21*
|
|
Form of Incentive Stock Option Agreement under 2010 Stock Incentive Plan.
|
|
8-K
|
|
5/28/2010
|
|
10.2
|
|
|
|
10.22*
|
|
Form of Nonstatutory Stock Option Agreement under 2010 Stock Incentive Plan.
|
|
8-K
|
|
5/28/2010
|
|
10.3
|
|
|
|
10.23*
|
|
Form of Restricted Stock Agreement under 2010 Stock Incentive Plan
|
|
|
|
|
|
|
|
X
|
|
10.24*
|
|
Form of Nonstatutory Stock Option Agreement for
Inducement Grant Pursuant to NASDAQ Stock Market Rule 5635(c)(4)
|
|
|
|
|
|
|
|
X
|
|
10.25*
|
|
Amendment No. 1 to 2010 Stock Incentive Plan.
|
|
8-K
|
|
12/14/2010
|
|
99.2
|
|
|
|
10.26*
|
|
Amendment No. 2 to 2010 Stock Incentive Plan.
|
|
8-K
|
|
5/18/2012
|
|
99.1
|
|
|
|
10.27*
|
|
Amendment No. 3 to 2010 Stock Incentive Plan.
|
|
8-K
|
|
6/13/2013
|
|
10.1
|
|
|
|
10.28*
|
|
Amendment No. 4 to 2010 Stock Incentive Plan.
|
|
8-K
|
|
6/13/2013
|
|
10.1
|
|
|
|
10.29*
|
|
Amendment No. 5 to 2010 Stock Incentive Plan.
|
|
8-K
|
|
6/16/2015
|
|
10.1
|
|
|
|
10.30*
|
|
2013 Employee Stock Purchase Plan, as amended.
|
|
8-K
|
|
6/13/2013
|
|
99.1
|
|
|
|
|
|
|
|
Incorporated by Reference
|
|||||||
Exhibit No.
|
|
Description
|
|
Form
|
|
SEC
Filing
date
|
|
Exhibit
Number
|
|
Filed
with
this
10-K
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agreements With Executive Officers
|
|||||||||||
10.31*
|
|
Offer Letter between the Registrant and Lawrence E. Bloch, M.D., J.D. dated May 15, 2012.
|
|
8-K
|
|
7/25/2012
|
|
10.1
|
|
|
|
10.32*
|
|
Offer Letter between IDI and Adelene Perkins dated as of February 6, 2002.
|
|
8-K
|
|
9/18/2006
|
|
10.11
|
|
|
|
10.33*
|
|
Amendment to Offer Letter between IDI and Adelene Perkins dated as of October 25, 2007.
|
|
8-K
|
|
10/30/2007
|
|
99.5
|
|
|
|
10.34*
|
|
Offer Letter between the Registrant and Seth A. Tasker, J.D. dated February 22, 2008
|
|
|
|
|
|
|
|
X
|
|
10.35*
|
|
Employment Retention Incentive Package Letter Agreement between the Registrant and Seth Tasker, J.D. dated July 1, 2016
|
|
|
|
|
|
|
|
X
|
|
10.36*
|
|
Offer Letter between the Registrant and Jeffrey Kutok, M.D., Ph.D. dated October 26, 2010
|
|
|
|
|
|
|
|
X
|
|
10.37*
|
|
Employment Retention Incentive Package Letter Agreement between the Registrant and Jeffery Kutok, M.D., Ph.D. dated July 1, 2016
|
|
|
|
|
|
|
|
X
|
|
10.38*
|
|
Severance Agreement between the Registrant and William Bertrand, dated June 28, 2016.
|
|
|
|
|
|
|
|
X
|
|
10.39*
|
|
Severance Agreement between the Registrant and Sujay Kango, dated October 31, 2016.
|
|
|
|
|
|
|
|
X
|
|
10.40*
|
|
Severance Agreement between the Registrant and Julian Adams, dated December 30, 2016.
|
|
|
|
|
|
|
|
X
|
|
10.41*
|
|
Infinity Pharmaceuticals, Inc. Executive Severance Benefits Plan effective February 6, 2013.
|
|
8-K
|
|
2/12/2013
|
|
10.1
|
|
|
|
Subsidiaries
|
|||||||||||
21.1
|
|
Subsidiaries of the Registrant. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
Consent
|
|||||||||||
23.1
|
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
Certifications
|
|||||||||||
31.1
|
|
Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
32.1
|
|
Statement of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
32.2
|
|
Statement of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith.
|
|
|
|
|
|
|
|
X
|
|
101
|
|
The following materials from the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2016, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations and Comprehensive Loss, (iii) the Consolidated Statements of Cash Flows, (iv) the Consolidated Statements of Stockholders’ Equity, and (v) Notes to Consolidated Financial Statements.
|
|
|
|
|
|
|
|
X
|
*
|
Indicates management contract or compensatory plan
|
†
|
Confidential treatment has been requested and/or granted as to certain portions, which portions have been filed separately with the Securities and Exchange Commission.
|
Definition:
|
Section:
|
AAA
|
12.2.3
|
Agreement
|
Preamble
|
Arbitration Request
|
12.2.1
|
Approval Reimbursement Event
|
3.1.2.(c)(i)(2)
|
Audit Opinion
|
6.6
|
Audited Financial Statements
|
6.6
|
Breaching Party
|
11.2
|
Clinical Site Agreement
|
1.3.6
|
Development Plan
|
3.1.1
|
Disclosing Party
|
1.10
|
DUO Reimbursement Event
|
3.1.2.(c)(i)(1)
|
Effective Date
|
Preamble
|
Existing Confidentiality Agreement
|
1.10
|
Existing IPI-145 Product
|
6.1.1(d)
|
Existing Patents
|
9.2.4
|
Headlicense Breach
|
2.5.5
|
Holdback Payment
|
3.1.2(b)
|
Indemnified Party
|
10.3
|
Indemnifying Party
|
10.3
|
Independent Auditor
|
6.6
|
INFI
|
Preamble
|
INFI Acquirer
|
12.6.1
|
INFI Pre-Existing Affiliates
|
12.6.1
|
Initiating Party
|
7.6
|
INK
|
1.37
|
INK Mark
|
7.8.1
|
Infringed Patent Right
|
6.1.1(d)
|
Insurance Period
|
10.6.1
|
Joint Know-How
|
7.2
|
Joint Patent Rights
|
7.2
|
Licensee
|
Preamble
|
Licensee Common Stock
|
3.1.2(c)(ii)
|
Licensee Acquirer
|
12.6.2
|
Licensee Pre-Existing Affiliates
|
12.6.2
|
Losses
|
10.1
|
MICL
|
1.56
|
Definition:
|
Section:
|
MICL Repayment Amount
|
6.1.3(b)(i)
|
MICL Royalty Payment
|
6.1.3(b)(i)
|
MICL Trailing Royalty Payment
|
6.1.3(c)
|
Non-Breaching Party
|
11.2
|
Paragraph IV Certification
|
7.4
|
Party or Parties
|
Preamble
|
Patent Term Extensions
|
7.9.1
|
Product Mark
|
2.5.1
|
Prosecution Patent Rights
|
7.3.1(a)
|
Purdue
|
1.56
|
Purdue Repayment Amount
|
6.1.3(b)(ii)
|
Purdue Royalty Payment
|
6.1.3(b)(ii)
|
Receiving Party
|
1.11
|
Registration Statement
|
3.1.2(c)(iv)
|
Reimbursable Amount
|
3.1.2(c)(i)
|
Reimbursement Announcement Date
|
3.1.2(c)(i)
|
Reimbursement Notice
|
3.1.2(c)(i)
|
Representatives
|
8.2.1
|
Reviewing Party
|
8.5
|
Royalty Termination Date
|
6.1.1(b)
|
SEC
|
3.1.2(c)(iv)
|
SEC Financial Statements
|
6.6
|
Securities Act
|
3.1.2(c)(ii)
|
Superseded Agreement
|
Preamble
|
Term
|
11.1
|
Third Party Infringement
|
7.4
|
Transition Plan
|
3.2.1
|
Transition Period
|
3.2.1
|
Unaudited Financial Statements
|
6.6
|
U.S. GAAP
|
1.58
|
Annual Net Sales of IPI-145 Product
|
Royalty Rate
|
The portion less than US$[**]
|
[**]%
|
The portion greater than or equal to US$[**] and less than US$[**]
|
[**]%
|
The portion greater than or equal to US$[**] and less than US$[**]
|
[**]%
|
The portion greater than or equal to US$[**]
|
[**]%
|
INFINITY PHARMACEUTICALS, INC.
By: _
/s/ Adelene Q. Perkins
_____________
Name:___
Adelene Q. Perkins
___________
Title: __
CEO and Chair
________________
|
VERASTEM, INC.
By: __
/s/ Robert Forrester
_______________
Name: __
Robert Forrester
______________
Title: __
CEO
_________________________
|
Mark (Class)
|
Country
|
Status
|
Filing No.
|
Filing Date
|
Reg. No.
|
Reg. Date
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
By:
|
Alexandria Real Estate Equities, L.P.,
|
By:
|
ARE-QRS Corp.,
a Maryland corporation, general partner |
Name of recipient (the “
Participant
”):
|
[Name]
|
Grant Date:
|
[Date]
|
Number of shares of restricted common stock awarded (the “
Restricted Shares
”):
|
[# of Shares]
|
Vesting is based on the achievement of performance metrics set forth on
Exhibit A
and on the Participant remaining an Eligible Participant on each applicable Vesting Date, as provided herein. No more than the Number of Restricted Shares set forth above may vest pursuant to this award.
|
INFINITY PHARMACEUTICALS, INC.
By:___________________________
Name of Officer
Title:
|
Signature of Participant |
Street Address |
City/State/Zip Code |
|
INFINITY PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
PARTICIPANT
|
|
|
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Address:
|
|
|
|
|
|
|
|
|
Telephone:
|
|
1.
|
Effective Date:
The effective date of your full-time employment with the Company shall be Monday, March 17, 2008.
|
2.
|
Salary:
Your base salary will be $5,076.93 per biweekly pay period (equivalent to $132,000 on an annualized basis). In addition, in accordance with the Company’s regular compensation practices, you will receive, approximately annually, a salary review, and the Company may adjust your salary based on your performance, the Company’s performance, and/or such other factors as may be determined at the sole discretion of the Company’s Board of Directors or its designee.
|
3.
|
Sign-on Bonus:
The Company will pay you a bonus of $7,000.00 on the date of the first paycheck following commencement of your full-time employment. Should you terminate for any reason within 12 months of your starting date after having received your bonus, the Company reserves the right to seek repayment of all or a pro-rata portion of your bonus.
|
4.
|
Contingent Compensation:
In addition to your salary and benefits, you may be eligible to participate in the Infinity Contingent Compensation program. This program may result in a cash bonus, depending on your and the Company’s achievements of goals and objectives, as well as overall business conditions. The Contingent Compensation program is administered by the Company's Board of Directors in their sole discretion. In order to be eligible for any type of payment under the program, you must be actively employed by the Company at the time the payment is made.
|
5.
|
Benefits:
You may participate in any and all of the benefit programs that the Company establishes and makes available to its employees from time to time, provided you are eligible under (and subject to all provisions of) the plan documents governing these programs.
|
6.
|
Vacation:
Upon your date of hire, you will start to accrue vacation time at a rate of 15 days per year, which may be taken in accordance with Company policy; 12 paid holidays annually will be observed.
|
7.
|
Equity Participation, Vesting of Stock:
Subject to approval by the Company’s Board of Directors, you will be granted a stock option exercisable for 6,000 shares of the Company’s Common Stock. A complete description of the terms and conditions of the stock option award will be contained in the Infinity Pharmaceuticals 2000 Stock Incentive Plan and the form of stock option agreement to be entered into by you and the Company. The option will vest as to one fourth (1/4) of the shares on the first anniversary of your commencement of full-time employment with the Company and as to one forty-eighth (1/48) of the shares monthly thereafter until all shares are vested, provided that you remain employed by the Company. In addition, in accordance with the Company’s compensation practices, you will receive, approximately annually, a merit stock review which shall be based on your performance, the Company’s performance, and other such factors as may be determined by the Company’s Board of Directors.
|
8.
|
Employment At-Will:
Your employment with the Company will be at-will, meaning that you will not be obligated to remain employed by the Company for any specified period of time and the Company will not be obligated to continue your employment for any specific period. Both you and the Company may terminate the employment relationship, with or without cause, at any time, with or without notice. Similarly, nothing in this letter shall be construed as an agreement, either express or implied, to pay you any compensation or grant you any benefit beyond the end of your employment with the Company (except as described herein).
|
9.
|
Proprietary Information, No Conflicts:
As a condition of employment, you agree to execute the Company’s standard form of Invention, Non-Disclosure, and Non-Competition Agreement and to be bound by all of the provisions thereof. You hereby represent that you are not presently bound by any employment agreement, confidential or proprietary information agreement, or similar agreement with any current or previous employer that would impose any restriction on your acceptance of this offer or that would interfere with your ability to fulfill the responsibilities of your position with the Company.
|
10.
|
Employment Eligibility Verification:
Please note that all persons employed in the United States are required to complete an Employment Eligibility Verification Form on the first day of employment and to submit an original document or documents that establish identity and employment eligibility within three business days of employment.
|
11.
|
Successors and Assigns:
This letter of offer will be binding upon and inure to the benefit of the Company’s successors and assignees. In the event of a merger or consolidation (whether or not the Company is the surviving or the resulting corporation), the surviving or resulting corporation will be bound by the obligations set forth in this letter offer.
|
1.
|
Salary:
Your base salary will be $10,769.23 per biweekly pay period (equivalent to $280,000.00 on an annualized basis). In addition, in accordance with the Company’s regular compensation practices, you will receive, approximately annually, a salary review, and the Company may adjust your salary based on your performance, the Company’s performance, and/or such other factors as may be determined at the sole discretion of the Company’s Board of Directors or its designee.
|
2.
|
Contingent Compensation:
In addition to your salary and benefits, you may be eligible to participate in the Infinity Contingent Compensation program, beginning in 2011. This program may result in a cash bonus, depending on your and the Company’s achievements of goals and objectives, as well as overall business conditions. The Contingent Compensation program is administered by the Company's Board of Directors in their sole discretion. For those hired within the plan year, your cash bonus payment will be pro-rated based on your hire date. In order to be eligible for any type of payment under the program, you must be actively employed by the Company at the time the payment is made.
|
3.
|
Benefits:
You may participate in any and all of the benefit programs that the Company establishes and makes available to its employees from time to time, provided you are eligible under (and subject to all provisions of) the plan documents governing these programs.
|
4.
|
Vacation:
Upon your date of hire, you will start to accrue vacation time at a rate of 15 days per year, which may be taken in accordance with Company policy; 12 paid holidays annually will be observed.
|
5.
|
Equity Participation, Vesting of Stock:
Subject to approval by the Company’s Board of Directors, you will be granted a stock option exercisable for 10,000 shares of the
|
6.
|
Employment At-Will:
Your employment with the Company will be at-will, meaning that you will not be obligated to remain employed by the Company for any specified period of time and the Company will not be obligated to continue your employment for any specific period. Both you and the Company may terminate the employment relationship, with or without cause, at any time, with or without notice. Similarly, nothing in this letter shall be construed as an agreement, either express or implied, to pay you any compensation or grant you any benefit beyond the end of your employment with the Company (except as described herein).
|
7.
|
Proprietary Information, No Conflicts:
As a condition of employment, you agree to execute the Company’s standard form of Invention, Non-Disclosure, and Non-Competition Agreement and to be bound by all of the provisions thereof. You hereby represent that you are not presently bound by any employment agreement, confidential or proprietary information agreement, or similar agreement with any current or previous employer that would impose any restriction on your acceptance of this offer or that would interfere with your ability to fulfill the responsibilities of your position with the Company.
|
8.
|
Employment Eligibility Verification:
Please note that all persons employed in the United States are required to complete an Employment Eligibility Verification Form on the first day of employment and to submit an original document or documents that establish identity and employment eligibility within three business days of employment.
|
9.
|
Successors and Assigns:
This letter of offer will be binding upon and inure to the benefit of the Company’s successors and assignees. In the event of a merger or consolidation (whether or not the Company is the surviving or the resulting corporation), the surviving or resulting corporation will be bound by the obligations set forth in this letter offer.
|
10.
|
Contingencies:
This offer is expressly contingent upon the successful completion of a pre-employment background and reference checks.
|
5.
|
Waiver of Rights and Claims Under the Age Discrimination
|
/s/William Bertrand
|
William Bertrand
|
Date:
|
9/2/2016
|
Dated:
|
|
|
|
|
|
|
William Bertrand
|
|
|
|
|
Dated:
|
|
|
|
|
|
|
Witness:
|
5.
|
Waiver of Rights and Claims Under the Age Discrimination
|
/s/Sujay Kango
|
Sujay Kango
|
Date:
|
January 9, 2017
|
Dated:
|
|
|
|
|
|
|
Sujay Kango
|
|
|
|
|
Dated:
|
|
|
|
|
|
|
Witness:
|
Title
|
Age
(as of 10/31/2016)
|
Age
(as of Termination Date)
|
Senior Statistical Programmer..
|
34
|
34
|
Senior Contracts Manager..
|
35
|
35
|
Clinical Project Manager..
|
35
|
35
|
Associate Director, Market Insights..
|
37
|
37
|
Associate Director, Data Management..
|
38
|
39
|
Clinical Project Manager..
|
39
|
39
|
Director, Program Management..
|
40
|
40
|
Director, Medical Writing..
|
40
|
40
|
Vice President, Product Development..
|
41
|
41
|
Senior Clinical Scientist..
|
42
|
42
|
Senior Director, Quality Assurance..
|
42
|
42
|
Vice President, Commercial..
|
43
|
43
|
Senior Director, Clinical Development..
|
44
|
44
|
Senior Medical Director, Clinical Development..
|
46
|
46
|
Vice President, Marketing..
|
46
|
47
|
Associate Director, Clinical Operations..
|
49
|
49
|
Senior Director, Biostatistics..
|
52
|
53
|
Chief Commercial Officer..
|
53
|
53
|
Vice President, Regulatory Affairs and Quality Assurance..
|
53
|
53
|
Title
|
Age
(as of 10/31/2016)
|
Accounting Manager..
|
28
|
Associate Director, Supply Operations..
|
35
|
Associate Director, Accounting..
|
35
|
Vice President, General Counsel..
|
38
|
Associate Director, IT..
|
45
|
Senior Medical Director, Safety & Risk Management..
|
45
|
Director, Clinical Development..
|
47
|
Senior Director, Pharmaceutical Development..
|
48
|
Receptionist/Administrative Associate..
|
52
|
Senior Medical Director, Clinical Development..
|
52
|
Executive Vice President, CFO, CBO..
|
53
|
Director, Pharmaceutical Development..
|
53
|
Vice President, Clinical Development..
|
56
|
Chair, President and Chief Executive Officer..
|
57
|
Group Leader, Accounting..
|
57
|
President of Research and Development..
|
61
|
5.
|
Waiver of Rights and Claims Under the Age Discrimination
|
/s/Julian Adams
|
Julian Adams
|
Date:
|
January 6, 2017
|
Dated:
|
January 6, 2017
|
|
/s/Julian Adams
|
|
|
|
Julian Adams
|
|
|
|
|
Dated:
|
January 6, 2017
|
|
/s/Seth A. Tasker
|
|
|
|
Witness:
|
|
|
|
Name
|
Jurisdiction of Organization
|
Percentage Ownership
|
Infinity Discovery, Inc.
|
Delaware
|
100%
|
Infinity Security Corporation
|
Massachusetts
|
100%
|
Infinity Discovery UK Limited
|
United Kingdom
|
100%
|
(1)
|
Registration Statement (Form S-3 No. 333-209661) of Infinity Pharmaceuticals, Inc.,
|
(2)
|
Registration Statement (Form S-8 No. 333-44850) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. Employee Stock Purchase Plan (formerly named the Discovery Partners International, Inc. 2000 Stock Incentive Plan and the Discovery Partners International, Inc. Employee Stock Purchase Plan, respectively),
|
(3)
|
Registration Statement (Form S-8 No. 333-97173) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. 2000 Employee Stock Purchase Plan (formerly named the Discovery Partners International, Inc. 2000 Stock Incentive Plan and the Discovery Partners International, Inc. 2000 Employee Stock Purchase Plan, respectively),
|
(4)
|
Registration Statement (Form S-8 No. 333-138248) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. Pre-Merger Stock Incentive Plan,
|
(5)
|
Registration Statements (Form S-8 Nos. 333-145306, 333-151135, 333-156641 and 333-164207) pertaining to the Infinity Pharmaceuticals, Inc. 2000 Stock Incentive Plan,
|
(6)
|
Registration Statements (Form S-8 Nos. 333-167488 and 333-182005) pertaining to the Infinity Pharmaceuticals, Inc. 2010 Stock Incentive Plan, and
|
(7)
|
Registration Statements (Form S-8 Nos. 333-189342 and 333-205585) pertaining to the Infinity Pharmaceuticals, Inc. 2010 Stock Incentive Plan and the Infinity Pharmaceuticals, Inc. 2013 Employee Stock Purchase Plan;
|
/s/ Ernst & Young LLP
|
|
|
|
|
|
Date: March 14, 2017
|
|
|
/
S
/ A
DELENE
Q. P
ERKINS
|
|
|
|
Adelene Q. Perkins
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: March 14, 2017
|
|
|
/s/ L
AWRENCE
E. B
LOCH
, M.D., J.D.
|
|
|
|
Lawrence E. Bloch, M.D., J.D.
|
|
|
|
President
|
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
|
|
|
|
Date: March 14, 2017
|
|
|
/
S
/ A
DELENE
Q. P
ERKINS
|
|
|
|
Adelene Q. Perkins
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
Date: March 14, 2017
|
|
|
/s/ Lawrence E. Bloch, M.D., J.D.
|
|
|
|
Lawrence E. Bloch, M.D., J.D.
|
|
|
|
President
|
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|